IBI308 in Subjects With Advanced / Metastatic Solid Malignancies

Status: Active

Description

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced / metastatic solid malignancies. Patients will be recruited for 2 cohorts: • Cohort 1: Advanced / metastatic cancers with TMB>10 mutations per megabase (mut / Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first. Cohort 2: Advanced / metastatic endometrial cancer (N=40)

Eligibility Criteria

Inclusion Criteria

Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.

Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 90 days following the last dose of study drug. Postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential.

Male or female subjects ≥18 years

At least one measurable lesion (per RECIST version 1.1)

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

Subjects with life expectancy of ≥ 3 month

If subject received anti-tumor therapy:

Generalized radiation therapy must have been completed 3 weeks prior to enrollment, or local radiotherapy or radiation therapy for bone metastases for 2 weeks prior to enrollment. Treatment with radiopharmaceuticals must have been completed 8 weeks prior to enrollment.

Previous chemotherapy, biotherapy (tumor vaccines, cytokines, or growth factors that control cancer), tyrosine kinase inhibitors, or approved targeting and other treatments should have completed at least 3 weeks prior to the first administered dose in this study;

Exclusion Criteria

Legal incapacity or limited legal capacity.

Pregnancy, lactation, breastfeeding.

Concurrent anticancer treatment (e.g., cytoreductive therapy or cytokine therapy except for erythropoietin) or use of other investigational product within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy. Note: Small molecule or antibody targeted therapy < 3 weeks from start of trial treatment will be excluded.

Received a biologic (G-CSF, GM-CSF) within 14 days prior to the first dose of study drug.

Vaccination within 4 weeks of first dose of IBI308 and while on study except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)

Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade 1 or baseline with the exception of alopecia;

Active autoimmune disease requiring systemic treatment within the past 1 year or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents during the conduct of this study. Exceptions: - Vitiligo, eczema, psoriasis (<10% of body surface area (BSA) of skin eruption or systemic involvement) or resolved childhood asthma/atopy, autoimmune hypothyroidism stable on hormone replacement.

History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis.

Subject who have had severe infection within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.

Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia